MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical product: 00801803202, femoral head, lot 61664620.Event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2018-00886.

Event Description

It was reported that approximately 7 years post implantation, the patient was revised due to dislocation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Pre revision x rays were provided.Review of the x-rays identified no contributing factors that would contribute to the recurrent dislocations that were identified.Review of the device history records identified no deviations or anomalies that may have caused or contributed to the reported event.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: LINER STANDARD 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8200520
• MDR Text Key: 131533573
• Report Number: 0001822565-2018-07057
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00630505832
• Device Lot Number: 61660311
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention